Practical guide to clinical data management third edition
This third edition emphasizes the EDC process. The chapters in the text are organized to represent the main elements of CDM: study startup, study conduct, and study closeout. In addition, a new chapter on the clinical trial process explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow. More details. Susanne Prokscha 2 books0.
Search review text. Toggle navigation. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture EDC for most studies.
It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers. Get Books. The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment.
Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the. Medical Data Management. Medical Data Management is a systematic introduction to the basic methodology of professional clinical data management. It emphasizes generic methods of medical documentation applicable to such diverse tasks as the electronic patient record, maintaining a clinical trials database, and building a tumor registry.
There is a focus on the international classification of diseases ICD-9 and systems, as well as a discussion on the difference between the two codes. All chapters feature exercises, bullet points, and a summary to provide the reader with essential points to remember. New to the Third Edition is a comprehensive section comprised of a combined Thesaurus and Glossary which aims to clarify the unclear and sometimes inconsistent terminology surrounding the topic.
This extensively updated fifth edition reflects the current knowledge in Health Informatics and provides learning objectives, key points, case studies and references. Available as a printed copy and E-book. Author : J. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics.
Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines. Author : Joanne V. Comprehensive in scope, it distills best practice information from numerous sources to facilitate utmost competency for APN and DNP graduates.
The third edition keeps pace with the rapidly evolving healthcare market by presenting a more comprehensive range of evaluation strategies for analyzing quality, safety, and value in healthcare practice and programs. It provides a completely new chapter on evaluation of simulation programs to improve clinician competency and patient care technology.
An increased focus on the application of quality improvement is woven throughout, including the quality improvement-research continuum and an emphasis on interdisciplinary collaboration and teamwork. The text also delves into the theoretical basis of evaluation and its application as an integral part of contemporary practice. It includes evaluation models that enable nurses to address economic and financial viability, and guides readers through the translation of outcomes from evaluation into health care policy.
Additionally, the text now includes PowerPoints for instructors. New to the Third Edition: New chapter: Evaluation of Simulation to Support Ongoing Competency in the HC Workforce Additional case studies and specific examples from QI projects Increased focus on teamwork and collaboration Enhanced discussion of theoretical foundations of evaluation approaches New focus on program evaluation and dissemination of findings Key Features: Addresses AACN competencies and scope of practice Helps students integrate best and evidence-based practices into care Provides guidance on practical methods and tools for Quality Improvement Project Presents evaluation models enabling nurses to address economic and financial viability Includes evaluations of organizations, systems, standards for practice, health care redesign, and the challenges of electronic medical records.
Author : Stephen B. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop.
Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology.